Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Leas-Chathaoirleach and I am delighted to be in Seanad Éireann two days in a row. I am pleased to introduce the CervicalCheck Tribunal Bill 2019 to Seanad Éireann. At the outset, I acknowledge the sincere bi-partisan effort in the other House, which I know will be in this House too, to get this done so that we can provide an alternative pathway to court for women seeking answers and justice in the botched CervicalCheck audit. I sincerely thank Members for taking this legislation so promptly and facilitating this debate.

I wish advise Members that the Dáil Business Committee agreed to waive pre-legislative scrutiny in the case of this Bill to enable the Houses of the Oireachtas to consider it with a view to enactment before our summer recess, and certainly before the Seanad's summer recess. Meeting this milestone will enable the tribunal to be established before the end of the year and to begin hearing cases as soon as possible. For women, some of whom are unwell, this timeline is obviously crucial.

The purpose of this important legislation is to establish an independent statutory tribunal to deal with claims arising from the CervicalCheck controversy. The Bill is based on the recommendations set out by Mr. Justice Charles Meenan in his 2018 Report on An Alternative System For Dealing With Claims Arising From Cervical Check. I thank the excellent Mr. Justice Charles Meenan for giving his time and sharing his expert advice in this regard. We have tried to stay true to his findings and recommendations in that report.

Following the issues which emerged last year, it is safe to say there is much greater awareness of the limitations of cervical screening and screening in general, and we will be aware that false negatives and false positives arise in all screening programmes in Ireland and internationally. As Mr. Justice Meenan noted in his report, where a woman develops cervical cancer following a negative smear test, this is not, in and of itself, evidence of negligence. There is a difference between a false negative and negligence. To establish negligence evidence has to be given from a suitably qualified expert that the reading of the smear fell below the appropriate standard required, and this evidence needs to be adjudicated on.

Recognising that any alternative system to the court process would need to recognise the issue of liability, Mr. Justice Meenan proposed that a tribunal be established under statute for the purpose of hearing and determining claims arising in relation to CervicalCheck. This Bill does exactly that. It also provides, very importantly, for restoration of trust meetings. That is a really important point because trust has been broken and damaged. I have met many of the women impacted from this situation. Those restoration of trust meetings could be of real value in getting to where we need to get to on our screening programme and in bringing a degree of closure and answers for the women involved.In that context, this Bill takes account of what Mr. Justice Meenan stated in his report and the views expressed by Dr. Gabriel Scally last year in the final report of the scoping inquiry into the CervicalCheck screening programme. Restoration of trust meetings is, of course, not part of the courts process but it is an important part of this legislation. We need to re-emphasise that the CervicalCheck screening programme has played a vital role in saving lives. We all know that. Despite its shortcomings and limitations regarding the audit process, we should not, and we will not, take away from that reality. It is, therefore, essential that women and their families have confidence in the programme and continue to use the programme.

Before going into the detail of the Bill, I would like to give further context and set out some of the important steps taken so far to deal with CervicalCheck issues. These include the reports by Dr. Gabriel Scally, supports for women and their families, and changes to the HSE's open disclosure policy and practice. A further significant initiative is the ex gratiascheme for women affected by non-disclosure. Payments have so far been made to more than 80 individuals impacted by non-disclosure. The scheme's independent assessment panel met and is continuing its work. I understand that further payments will be made in the coming days. We are, crucially, implementing the recommendations in Dr. Scally’s report in full and we have accepted the two further recommendations from his recent supplementary report. My aim, my vision and my policy, and that of this House, is to effectively eradicate cervical cancer. That is not pie in the sky and it is not a lofty political aspiration. It is something that we can do and it is something I genuinely believe that we will do through a combination of a robust screening programme, a move to HPV testing and, crucially, the introduction of the HPV vaccine for boys and the continuing promotion of the vaccine for girls.

We also have to push back against the myths - we are not allowed to say "lies" in this House - disinformation and misinformation that is put forward regarding vaccinations. I will bring forward a motion in support of the vaccination programme in the other House and I would also like to bring it into this House. I hope all of the Members of Seanad Éireann, regardless of party affiliation, will state clearly that they support the HPV vaccine for boys and girls and the child's immunisation programme. I hope as well that Members of both Houses will stop writing letters to me trying to question the validity of that vaccination. They are doing serious harm to people, present company excluded of course. There is, of course, a legitimate role for asking questions but giving succour to misinformation about vaccines has resulted in deaths in this country. I promised Laura Brennan that we will do everything we possibly can to reverse that trend. I know I have great cross-party support in this House for that approach as well.

The HSE continues to strengthen governance, quality assurance and management in the CervicalCheck programme and the wider national screening service in line with Dr. Scally’s recommendations. This is a key point. Great work was done by the CervicalCheck screening programme and that is still being done. It is fair to say, however, that it was somewhat operating as an island and a silo. When Dr. Scally looked closely at the programme, he found a real need for proper governance structures, proper management structures and clarity on how the programme links in with the wider health service.

Turning to supports for women affected, something important for all of us here, funding has been provided to the 221+ Patient Support Group to enable advocacy and supports to be made available to these patients. I also announced last year the establishment of a primary and social care support package for women and families affected by the CervicalCheck issues. This comprehensive package of supports is for the cohort of 221+ women for whom the audit carried out by CervicalCheck found discordance with the original reading of their slides. The package will also be provided to any other woman for whom the independent clinical expert review currently being undertaken by the Royal College of Obstetricians and Gynaecologists, RCOG, identifies discordance with her original smear test reading. Members will be aware that this review is ongoing and that its purpose is to provide women with independent clinical assurance about the quality of the screening programme and the timing of diagnosis and treatment.

I also want to mention open disclosure. This goes to the heart of the matter for many of the women concerned. Audits are a good thing and we should encourage them but we should also be disclosing and openly disclosing information. When things go wrong in our health service, and things go wrong in every health service, it is important that people disclose information. It is important that patients - women and men - get information. It is also important, however, that our clinicians can disclose in an environment where they know how that process will work. What we saw at the heart of the CervicalCheck audit debacle was mass confusion regarding what the open disclosure policy was and whose job it was to disclose.

I welcome the new open disclosure policy published by the HSE. It is in line with recommendation 28 of Dr. Scally’s report, which emphasised that the policy should be revised to reflect the primacy of the rights of patients to have full knowledge about their healthcare and, in particular, their right to be informed about failings in that care process, however, and whenever, they may arise. The interim policy will be further reviewed when the patient safety Bill is published. I look forward to returning to this House in the autumn with the full patient safety Bill, which will provide for mandatory open disclosure of patient safety incidents. It is at an advanced stage.

Turning now to this Bill, I want to present an overview of the general principles. The tribunal will hear and determine liability for claims regarding CervicalCheck, subject to the consent of all the parties to the claim. The Bill sets out who may make a claim and the period within which claims may be made. The Bill enables the tribunal to determine and adopt pre-claim protocols and enables the chairperson to issue practice directions regarding the conduct of claims, in the interests of hearing and determining claims in a manner which is just and expeditious. The tribunal’s determination of a claim may be appealed to the High Court. Where a claimant accepts an award and where no appeal is made, the tribunal will apply to the High Court for confirmation of that determination.

The tribunal’s hearings will be held otherwise than in public; in other words they will be held in private, except where the woman would like it to be held in public. This respects the privacy of the women concerned. I have met many of these women as others here have as well. The idea of those women having to tell their intimate life stories in a very public fashion is something that has discouraged many from going forward to seek justice and answers. The idea of having an opportunity to tell their stories in private in a less formal setting is something that we can welcome. It respects the privacy of the women concerned while giving them the opportunity to have hearings, or part of hearings, in public should they wish.

The tribunal will also facilitate restoration of trust meetings. The intention behind a restoration of trust meeting is to document experiences, facilitate discussion and provide information to the woman concerned or her family. In addition to these functions, the tribunal may also provide advice or recommendations to the Minister relating to its work. That is important because we will discuss over the next few days the various views on this Bill. My starting point, and frankly my finishing point, will be the fact that the judge will have the opportunity to keep in contact with my Department while being fully independent regarding any recommendations that she may wish to make. That should provide us with a degree of assurance in this House.

The Bill is divided into three Parts. Part 1 is the preliminary and general part, part 2 provides for the CervicalCheck tribunal and part 3 contains miscellaneous provisions. Section 1 is a standard section on the Short Title and commencement provisions. Section 2 is the definitions section. A key definition is the definition of "relevant woman", which is central to the scope of the tribunal regarding who may make a claim. These are women identified as part of the review of cervical screening as having had CervicalCheck cytology review findings that were discordant with those of the original cytology examination, or women whose cytology slides were re-examined as part of the retrospective CervicalCheck audit and whose cytology review findings were discordant with those of the original cytology examination. I brought forward an amendment on Committee Stage in the Dáil that extended eligibility to a small additional group of women whose slides could not be located in time for them to be examined as part of the review of cervical screening.

I want to let Senators know at this stage that I have committed, and commit again today, to returning to the Oireachtas in the autumn with a proposal to amend the legislation to allow women who declined to participate in the review of cervical screening a further opportunity to be included in the scope of the tribunal. At the moment, it is possible for a woman in the 221+ group and who has had a discordance, a woman who has gone through the RCOG process and had a discordance, or if it was not possible to go through that process because slides were missing, to have access to the tribunal. There will be another group of people who have decided, for their own reasons, which we should not second-guess, that they do not wish to be part of any review. I was asked in the other House if I would consider allowing that group one more opportunity to take part in an independent review and allowing them to access the tribunal if they say "yes" and a discordance is found. I happily conceded on that point and I will return to the Oireachtas in the autumn in respect of that matter.

Section 3 is a standard provision for expenses incurred by the Minister in the administration of the legislation. Part 2 contains sections 4 to 36, inclusive. Sections 4 to 10, inclusive, deal with establishing the tribunal and the tribunal's functions. Section 4 provides for the establishment day for the tribunal. I expect to establish the tribunal once the necessary arrangements are in place for it to begin its work. Section 5 provides for the establishment of the CervicalCheck tribunal. The tribunal may sit in divisions, it will be independent in the performance of its functions and will regulate its own procedures. Section 6 is the membership section. The tribunal will comprise a chairperson and not less than two ordinary members, appointed by me as the Minister for Health. As has been announced, Ms Justice Mary Irvine will be the chairperson. I thank her for accepting that role. The Minister may appoint additional persons to the tribunal, if necessary. The chairperson must hold or have held judicial office in the superior courts. Ordinary members must hold or have held judicial office in the superior courts or be a practicing barrister or solicitor of not less than ten years' practice.

The tribunal’s functions come under section 7. The tribunal shall hear and determine claims made to it, facilitate restoration of trust meetings and report on and make recommendations as it deems appropriate on any matter relating to its work.Section 8 deals with staff for the tribunal. Section 9 enables the tribunal to appoint people with expertise to provide it with advice or assistance. It also enables the tribunal to conduct or commission research, again subject to prior approval from me, as Minister, and the Minister for Public Expenditure and Reform. Section 10 allows the tribunal to appoint its own counsel.

Sections 11 to 13, inclusive, are concerned with the making of claims to the tribunal. These are important sections. Section 11 provides for claims before the tribunal and who may make claims. A claim may be made by an appropriate person and an appropriate person under the Bill is defined as a relevant woman or, where the woman is deceased, a dependant of the woman. A claim for compensation may be made seeking damages for negligence, breach of duty, breach of statutory duty or breach of contract arising from any act or omission concerning CervicalCheck. A claim may also be made seeking damages for the alleged negligence or breach of duty arising from an alleged failure to inform the relevant woman or her dependant of the results of the retrospective CervicalCheck audit. I have mentioned already the amendments made to this section and my plans in that regard. It is important to state that the legal principles as to liability and quantum of damages as applied in the High Court in respect of such cases will apply to claims before the tribunal. A claim may not be made where a person has received an award from any court or settlement in respect of any action arising from any circumstances which could give rise to a claim before the tribunal. The exception is an award under the ex gratiascheme.

Section 12 deals with reckoning of time for the purposes of the Statute of Limitations. In the case of a woman identified as part of the review of CervicalCheck, a claim must be made within nine months of establishment day for the tribunal or within six months of being notified of findings of the review of cervical screening, whichever is the later. In the case of other women within the scope of the tribunal, a claim must be made within nine months of the establishment day for the tribunal. A person may not make claim where the person was entitled to institute proceedings in respect of a relevant claim, and the limitation period in respect of instituting those proceedings has expired. However, the period beginning on the making of a claim and ending six months from the date on which the tribunal notifies the claimant that one or more of the relevant parties have failed to agree in writing to the claim being determined by the tribunal will be disregarded in reckoning any period for the purpose of limitations. As initiated, the Bill did not provide for the additional six months. I was pleased that my amendment to allow for the latter - on which I engaged with the Opposition - was accepted on Report Stage in the Dáil following constructive discussion at the Select Committee on Health. Similarly, the period beginning on the making of a claim and - following amendment - now ending six months from the date on which the tribunal notified the claimant that one or more of the relevant parties have notified the tribunal that they no longer consent to the claim being determined by the tribunal will also be disregarded in the reckoning of any period for the purpose of limitation periods regarding a claim.

Section 13 provides that the tribunal will hear and determine only claims in respect of which there is an agreement in writing from the relevant parties. The relevant parties are the claimant, the HSE and the cytology laboratory services retained by the HSE for CervicalCheck.

Sections 14 to 26, inclusive, provide for claims before the tribunal and procedures. Section 14 provides for the manner of determination of issues. The tribunal will hear and determine claims in the same manner as such matters are determined by the High Court in respect of claims for personal injuries. Section 15 provides for third-party procedures and consent issues. The tribunal may grant an application to join a third party to a claim in the same manner as such applications are determined by the High Court. The claim will proceed before the tribunal only where the third party consents to having all issues arising in the claim determined by the tribunal. Where the third party does not consent to having all issues arising in the claim determined by the tribunal, the tribunal shall not continue to hear and determine the claim.

Section 16 requires the tribunal to take into account any sum paid or payable to a claimant under the CervicalCheck non-disclosure ex gratiascheme when considering whether an award should be made regarding non-disclosure. Section 17 provides for applicable principles to awards of the tribunal. An award shall be made on the same basis as an award of the High Court. A claimant will have 21 days, or such longer period as the tribunal may determine, from the making of the award to accept or reject the award or to appeal the award. A claimant shall be deemed to have rejected the award where the claimant neither accepts or rejects the award nor appeals the award within the 21-day period or such greater period determined by the tribunal. Where the claimant decides to accept the award, the acceptance must be made in the prescribed form, which is a notice of acceptance and shall be accompanied by a waiver. I have committed to considering this provision further over the summer, because some women have raised concern over the concept of a waiver. The word "waiver" does not sit well with me either but I want to be clear that this provision only applies in a situation where a woman wishes to accept an award. Should a women be unsatisfied with an award, of course she is not expected to waive the right to take further action. I will look at the wording of the section. I am satisfied that the legal principles are sounds.

Rules contained in the Civil Liability Acts 1961 to 2017 shall be applied to the tribunal in the same manner as would be applicable in an assessment of damages were proceedings to be brought to the High Court regarding the claim. Section 18 provides that parties appearing before the tribunal shall be entitled to be legally represented. Section 19 provides that the tribunal may award costs in respect of a claim. Under section 20, hearings are generally to be otherwise than in public. However, a hearing or part of a hearing will be conducted in public where a claimant requests and the tribunal agrees that it would be appropriate to do so.

Section 21 provides for the form and manner in which evidence may be given. Section 22 provides for powers relating to witnesses and documents. Section 23 provides for privileges and immunities of witnesses. A person who gives evidence to the tribunal or who produces or sends documents to the tribunal, as directed by it, has the same immunities and privileges in respect of that evidence or those documents, and is subject to the same liabilities, as a witness in proceedings in the High Court.

Section 24 provides that the tribunal may apply to the High Court for directions relating to the performance of its functions or for the approval of the court of an act proposed to be done by the tribunal for the purposes of performing its functions. The High Court may hear an application otherwise than in public having regard to the subject matter or any other matter relating to the nature of the evidence to be given at the hearing of the application. An important section in the Bill is section 25 which enables the tribunal to determine and adopt pre-claim protocols. These are procedures governing requirements to be complied with before claims are brought. That is important. It is one of the big differences between the court process and the tribunal model. The aim is to promote timely communication between parties, facilitate early identification of the relevant parties, facilitate early identification of the issue in dispute in respect of a possible claim and facilitate the hearing and determination of claims in a manner which is just and expeditious. Section 25 also enables the chairperson to issue practice directions on the conduct of claims.

Section 26 provides for the tribunal to make rules to regulate practice and procedure and the conduct of claims. Section 27 provides for appeals. Section 28 provides for confirmation and publication of the tribunal's determinations. I was pleased to accept an amendment to this section on Report Stage. It now provides that confirmation will only be required where an award is accepted. Section 29 provides for enforcement of awards.

Sections 30 to 33, inclusive, have the restoration of trust provisions which I spoke about earlier and I also include provision for a facilitator in regard to the meetings. Section 31 provides for the appointment of a facilitator to carry on and control generally the administration and business of restoration of trust meetings. Importantly, the facilitator is independent in the performance of his or her functions. Section 32 sets out the detail in regard to restoration of trust meetings. It is important that real, open discussion takes place at those meetings and, accordingly, section 33 provides appropriate protections for participants. Evidence is not admissible in any court or the tribunal of any information, statement or admission disclosed or made in the course of a restoration of trust meeting. Information provided by a participant at a restoration of trust meeting will not invalidate professional indemnity insurance policies or contracts of insurance, nor will information provided at the meeting constitute an admission of fault. In other words, it must be a safe space for trust to be restored.

Sections 34 and 35 deal with the tribunal's recommendations and its annual reports. Under section 34, the tribunal may make recommendations to me as Minister and the Minister will publish any recommendations made by the tribunal to inject transparency. Section 35 requires the tribunal to prepare and submit the recommendations to the Minister and places an obligation on me to publish them. Section 36 provides for the dissolution of the tribunal and that the Minister may by order dissolve the tribunal. That would be done following consultation with the tribunal.

Part 3 provides for miscellaneous matters and has sections 37 to 40. Section 37 provides that where an appeal from a determination of the tribunal is made to the High Court, rules of court may make provision for the hearing and determination of those appeals in a timely and efficient manner. Section 38 provides for offences and penalties for offences. Section 39 provides for restriction of the data protection regulation to enable the tribunal, the facilitator and moderators to perform their functions.

The Bill is quite technical and it is important to put the information on the record of the House, as it is a Bill that will interest many. At its heart, what we are trying to do here is provide an alternative pathway to the courts system. People will always have a constitutional right to go to court. The Constitution is clear on that, but there is an onus on us to provide as many alternative pathways as possible. Through the State Claims Agency we have a process of mediation, which has settled a number of claims, including some high-profile ones. We have the courts system in its constitutional place. We have an ex gratiascheme for non-disclosure, where the State has said for the issue of non-disclosure we accept liability and an independent panel has agreed the figure of €20,000 to be paid out in that regard where non-disclosure took place, or not appropriate disclosure. The CervicalCheck tribunal is another alternative pathway. Is it perfect? Absolutely not. Is there a perfect model? Absolutely not. We are trying to do here something we have never done before. People hear the word "tribunal" and they think of the Mahon tribunal. That was a tribunal of investigation, this is not. We had Dr. Scally do his work. People also think of the hepatitis C tribunal. That was a compensation tribunal, this is not. In that case, it was quite straightforward - people had been injected with contaminated blood that did them serious damage and the State needed to care for and compensate them. In this instance, we know, because of the limitations of screening, that there will have been false negatives and false positives in some cases and that there was negligence. Where there was negligence, women have a right to have that determined. We want them to have it determined, if they so wish, in an alternative place to the High Court.This is an adjudicative tribunal and liability does have to be determined. We have been at this now for many months, trying to find the best and most compassionate way to do it. Greater minds than mine have looked at it. Mr. Justice Charles Meenan, one of the most eminent clinical negligence judges in the country, examined it in great detail. On page 20 of his report he published ten reasons it would operate better than the court system. For me, as a layperson, at its heart is that it can be done in private and people can submit written statements, which lessens the need to go and tell their whole story, unless they wish to do so. There are pre-action protocols; the judge can appoint her own experts and, where liability is not contested, the process can be fast-tracked. There are a number of ways in which it is less adversarial. However, it is not entirely so as there has to be that ability to adjudicate on and determine the issues of liability and negligence. I am happy that, after significant engagement by the judge with Dr. Scally, patient advocates, the State Claims Agency and the laboratories, this is the best model we can put in place. It is just one of a number of pathways we are trying to provide as alternatives to court.

I thank the House for taking the Bill as speedily as it has and hope we can endeavour to pass it in the coming days.